Vice President, Early Clinical Development, Radiopharmaceutical Therapies

Bristol Myers Squibb

3d•$341,360 - $413,648•Hybrid

About The Position

This role will report to the CMO and hold a key leadership position within the clinical development organization and will serve as the bridge between research, discovery, and clinical development. The Vice President of Early Development will lead the clinical strategy and medical oversight for the RayzeBio portfolio of next-generation radiopharmaceutical therapies. This role is responsible for the "First-in-Human" journey, transforming preclinical discoveries into robust, data-driven clinical programs that demonstrate early safety, biological activity, and therapeutic potential. This role provides medical direction and high quality scientific and clinical knowledge to lead the strategy and execution of RayzeBio’s clinical development plans for molecules in early development. Responsibilities include support for IND preparation, regulatory authority interactions, design and execution of Phase 0/1 FIH clinical trials. This role will lead cross-functional teams responsible for the design, implementation, monitoring, analysis, and reporting of studies conducted within RayzeBio’s portfolio to ensure the program meets the needs of patients and RayzeBio’s business. This role will engage with BMS oncology leaders in research and early clinical development to develop combination strategies as appropriate across the BMS and Rayze Bio portfolios.

Requirements

MD or PhD (MD/PhD preferred) with a specialization in Oncology, Nuclear Medicine, or a related field.
12+ years of drug development experience, with a proven track record of designing early-phase clinical protocols for radiopharmaceutical therapies.
Demonstrated leadership of clinical and cross-functional teams in a biotech environment.
A track record of designing dose-escalation studies (e.g., Bayesian Optimal Interval or 3+3 designs) specifically tailored for radioactive drugs.
Expertise in implementing the "image-then-treat" paradigm, specifically the clinical use of PET/CT imaging to predict therapeutic response for RPTs.
Proficiency in clinical dosimetry protocols to determine absorbed doses to organs-at-risk and tumors, ensuring patient safety and regulatory compliance.
Deep understanding of the specific safety profiles of radiopharmaceuticals, including hematological toxicities, nephrotoxicity, and other developing safety signals.
Ability to oversee the integration of quantitative imaging biomarkers into early-phase trials to assess target engagement and biodistribution.
Functional knowledge of "just-in-time" manufacturing, managing the clinical interface with radio pharmacies, and isotope shelf-life constraints in a trial setting.
Deep commitment to understanding needs and improving the lives of patients with cancers and a passion for developing novel therapeutics.
Motivated to work in a fast-paced, high accountability, small company environment.
A "can do" and collegial professional who leads through influence and interpersonal skills.
Demonstrated record of accomplishment in a compressed time frame; capable of prioritizing tasks and delivering on deadlines with high performance standards and attention to detail.
Demonstrated ability to manage multiple stakeholder engagements across development and commercial organizations.
Strong written and oral communication skills, including presentation skills.
Strong critical, strategic, and analytical thinking skills.
Experience in working closely with investigative sites, including principal investigators, sub-investigators, study coordinators and other site personnel involved in clinical trials.
Able to function in a highly regulated environment and to adhere to all RayzeBio guidelines and standard operating procedures (SOP’s).
Solid understanding of GCP and ICH guidelines.

Responsibilities

Design and execute innovative Phase 0/1 clinical trials.
Define the clinical path to proof-of-concept, including the use of theranostic pairs to accelerate patient selection.
Lead the translation of preclinical pharmacology and toxicology into First-in-Human dosing strategies.
Serve as the primary medical/scientific voice for the early-stage pipeline.
Collaborate with medical physicists to integrate radiation dosimetry into clinical protocols, ensuring optimized therapeutic windows and individualized patient safety.
Define the imaging strategy to provide early evidence of target engagement, biodistribution, and tumor response.
Act as the lead clinical expert for meetings with global health authorities (FDA/EMA).
Draft and defend clinical sections of IND/CTA filings, with a focus on justifying dose-escalation schemes and safety monitoring.
Support and lead interactions with the FDA’s Division of Medical Imaging and Radiation Medicine.
Establish a network of academic investigators and nuclear medicine specialists to ensure strategic alignment with changes in therapeutic landscapes and collaboration on early development programs.
Lead asset strategies for RayzeBio products in early clinical development.
Build and mentor the RayzeBio asset teams in clinical development.
Serve as manager and cross-functional leader across the RayzeBio organization.

Benefits

Medical, pharmacy, dental, and vision care.
BMS Well-Being Account, BMS Living Life Better, and Employee Assistance Programs (EAP).
401(k) plan, short- and long-term disability, life insurance, accident insurance, supplemental health insurance, business travel protection, personal liability protection, identity theft benefit, legal support, and survivor support.
Flexible time off (unlimited, with manager approval, 11 paid national holidays (not applicable to employees in Phoenix, AZ, Puerto Rico or Rayzebio employees)) for US Exempt Employees.
160 hours annual paid vacation for new hires with manager approval, 11 national holidays, and 3 optional holidays for Phoenix, AZ, Puerto Rico and Rayzebio Exempt, Non-Exempt, Hourly Employees.
Unlimited paid sick time.
Up to 2 paid volunteer days per year.
Summer hours flexibility.
Leaves of absence for medical, personal, parental, caregiver, bereavement, and military needs.
Annual Global Shutdown between Christmas and New Years Day.